Back to resultsThe Use of Brace to Retrain Hemiparetic Gait
Primary Purpose
Stroke Nos Without Residual Deficits
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bracing
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Nos Without Residual Deficits focused on measuring stroke,, rehabilitation,, hemiparesis,, gait training
Eligibility Criteria
Inclusion Criteria:
- the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.
Exclusion Criteria:
- conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bracing
Arm Description
Bracing: the patients began four weeks of training the gait with the brace, under the guidance and observation of the physiotherapist belonging to the group of authors of this study.
Outcomes
Primary Outcome Measures
distribution of plantar pressures during walking
To evaluate the distribution of plantar pressures during walking, for individuals with hemiparesis, before and after training with a brace for gait retraining and control of genu recurvatum.
To observe the gait evolution of 12 patientes after the trainnig with a orthotic device.
Secondary Outcome Measures
Full Information
NCT ID
NCT02082938
First Posted
March 4, 2014
Last Updated
March 6, 2014
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02082938
Brief Title
The Use of Brace to Retrain Hemiparetic Gait
Official Title
The Use of a Brace to Retrain Hemiparetic Gait in Patients With Genu Recurvatum: Effects on Plantar Pressure Distribution
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients.
Detailed Description
Objective To compare the behavior of plantar pressure peak distribution, before and after training using a brace for gait rehabilitation.
Method The brace was developed with the aim of promoting better biomechanical alignment, as well as providing proprioceptive information in order to stimulate action in the knee's flexor muscle groups, thus facilitating the activation pattern contrary to what occurs during genu recurvatum. We conducted a quasi-experimental "before and after" study with twelve hemiparetic adult patients who had genu recurvatum in the gait. The plantar pressure peaks were compared at the various moments of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Nos Without Residual Deficits
Keywords
stroke,, rehabilitation,, hemiparesis,, gait training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bracing
Arm Type
Experimental
Arm Description
Bracing: the patients began four weeks of training the gait with the brace, under the guidance and observation of the physiotherapist belonging to the group of authors of this study.
Intervention Type
Device
Intervention Name(s)
Bracing
Intervention Description
Twice a week, for a period of 5 weeks, before the sessions in the physiotherapy clinic the patients participating in the study were asked to walk at a self-selected speed on flat ground along a corridor 50 meters long, with the brace being used for fifteen minutes of gait retraining of the affected side.
Primary Outcome Measure Information:
Title
distribution of plantar pressures during walking
Description
To evaluate the distribution of plantar pressures during walking, for individuals with hemiparesis, before and after training with a brace for gait retraining and control of genu recurvatum.
To observe the gait evolution of 12 patientes after the trainnig with a orthotic device.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.
Exclusion Criteria:
conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Éder K Cardoso, Master
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Use of Brace to Retrain Hemiparetic Gait
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